19 patients were initially enrolled. Interim analysis raised concerns about toxicity, however, so the trial was temporarily closed. It later reopened with mild reductions in the chemotherapy dose (no change to the dosing of Bevacizumab).

Toxicity data are now available on the first 60 patients enrolled (the original 19 and 41 patients subsequently enrolled in the amended trial).

Toxicity data are presented here; data regarding tumor response are currently being compiled and are not yet available.

Results

15% of patients had grade 3 diarrhea; none had grade 4.

12% of patients had grade 3 vomiting and 2% had grade 4.

12% had grade 3 nausea.

A total of 33% had grade 3 or grade 4 neutropenia, though only 3 patients had febrile neutropenia.

Overall, these toxicities are equivalent to, or less than, those reported by Saltz, et al. in the literature regarding the chemotherapy regimen alone (minus the anti-VEGF).

The presenter stated, too, that nausea, vomiting, and dehydration was diminished in patients treated on the reduced-dosage chemotherapy regime compared with those treated prior to trial amendment.

There were some mild bleeding events, presumably related to the anti-VEGF agent.

Mild, self-limited epistaxis was fairly common. In addition, one patient had bleeding per rectum (possibly related to the primary tumor) and one had bleeding from a chest wall metastasis. One patient had epistaxis which required tamponade.

Author's Conclusions

Addition of Bevacizumab, an anti-VEGF agent, to a CPT-11 containing chemotherapy regimen, appears safe and well tolerated.

Clinical/Scientific Implications

Treatment with Bevacizumab, in conjunction with a CPT-11-containing chemotherapy regimen, dose not appear to result in untoward toxicity.

It remains to be seen whether this particular anti-VEGF agent produces clinical response in patients. Analysis of this data is ongoing.